title: Biochemical efficacy and safety of a new, ready-to-use, liquid alpha-1-proteinase inhibitor, GLASSIA (alpha1-proteinase inhibitor (human), intravenous).
abstract: Maintaining serum levels of alpha-1-proteinase inhibitor (A1PI) >11 μM by augmentation with plasma-derived human A1PI is currently the only specific therapy available to treat patients with the genetic deficiency of A1PI. In this study, a new, high-purity (≥90% A1PI in monomeric form), ready-to-use, liquid formulation of A1PI-GLASSIA (Kamada, Ness Ziona, Israel) was compared to PROLASTINÆ (Talecris, Research Triangle Park, NC, now Grifols), both commercially available, FDA-approved products. This multicenter, double-blind, randomized controlled trial with partial cross-over was designed to test the non-inferiority and safety of GLASSIA compared to PROLASTIN, assessing both antigenic and functional A1PI trough levels in subject serum. Non-inferiority of GLASSIA to PROLASTIN was demonstrated by remaining within the lower bounds of the confidence intervals (≤3 μM) for both antigenic and functional A1PI. The study concluded that GLASSIA, a new liquid, ready to use, formulation of A1PI, was not inferior to PROLASTIN and it was well tolerated with a safety profile comparable to PROLASTIN.
authors.affiliation: 1National Jewish Health , Denver, CO , USA.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Sandhaus
authors.forename: James
authors.initials: J
authors.lastname: Stocks
authors.forename: Farshid N
authors.initials: FN
authors.lastname: Rouhani
authors.forename: Mark
authors.initials: M
authors.lastname: Brantly
authors.forename: Pnina
authors.initials: P
authors.lastname: Strauss
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011656:Pulmonary Emphysema / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D000515:alpha 1-Antitrypsin / Q000627:therapeutic use*; D019896:alpha 1-Antitrypsin Deficiency / Q000150:complications / Q000188:drug therapy*
chemical_list: D000515:alpha 1-Antitrypsin